General Information
Revision date
2015-03-23
Product name
Woun"Dres
1.2.1 Relevant identified uses
Medical device Telephone: +45 49 11 11 11 Hydrates dry wounds and eschar. Promotes
Manufacturer Name
Coloplast A/S
Emergency telephone
(DK) +45 82 12 12 12
Icons in SDS
Company Information
company name
Coloplast A/S
e-mail address of the competent person responsible for the Safety Data Sheet
msds@coloplast.com
GHS Information
Signal word
-
Section 2
SECTION 2: Hazards identification
1272/2008 This product is regulated as a medical device in the European Economic Area (EEA). In other regions it may be regulated as a medical device, a cosmetic or not regulated. The product is assessed and supplied with a safety data sheet in accordance with Regulation (EC) no 1272/2008. Labelling of the product is prepared in accordance with Directive 93/42/EEC on medical de- vices and local legislation.
EU Classification
Regulation (EC) No 1272/2008: The product shall not be classified as hazardous ac- cording to EU classification and labelling rules. Wording of R-sentences and H-statements – see Most serious harmful effects: May cause slight irritation to the skin and eyes.
2.2 Label elements
The product is a medical device in EAA and therefore the labelling elements from the CLP regulations do not apply, according to Regulation (EC) No 1272/2008, Title I, Article 1, Section 5. The product shall not be classified as harzardous according to EU classifica- tion and labelling rules. According to Regulation (EC) No 1272/2008:
2.3 Other hazards
Assessment to determine PBT and vPvB has not been made.
